User Performance of the CONTOUR NEXT and CONTOUR TV3 Blood Glucose Monitoring System (BGMS)

Launched by ASCENSIA DIABETES CARE · Nov 1, 2018

Keywords

ClinConnect Summary

This clinical trial will assess the performance (accuracy) of the CONTOUR NEXT and the CONTOUR TV3 monitoring systems ("BGMS") by lay users enrolled as subjects in the study, and by health care professionals. According to a randomization schedule, subjects will be assigned to use either the CONTOUR NEXT or CONTOUR TV3 meters first and then switch and use the second meter, performing the same testing with both meters. They will learn to use the assigned meter by reading the corresponding User Guide (UG) and Quick Reference Guide (QRG). Each subject will perform one fingerstick self-test a pa...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Males and females, 18 years of age and older
• • Ability to speak, read and understand English. Subjects must demonstrate ability to read a paragraph from the first page of the User Guide to qualify for the study.
• • Willing to complete all study procedures.
• Exclusion Criteria:
• • Hemophilia or any other bleeding disorder.
• • Pregnancy (self-reported).
• • Physical, visual or neurological impairments that would make the person unable to perform testing with the BGMS.
• • Previous participation in a blood glucose monitoring study using the Ascensia CONTOUR NEXT or CONTOUR TV3 BGMS.
• • Working for a medical laboratory, hospital or other clinical setting that involves training on or clinical use of blood glucose monitors.
• • Working for a competitive medical device company, or having an immediate family member or someone who is not a family member but is living within the household of someone who works for such a company.
• • A condition, which in the opinion of the investigator or designee, would put the person or study conduct at risk.